BMS, Bavarian Nordic Form Supply Pact for NSCLC Clinical Study

Bristol-Myers Squibb and Bavarian Nordic, a Kvistgaard, Denmark-based biotechnology company focused on cancer immunotherapies and vaccines, have signed a drug supply agreement for BMS to supply its immuno-oncology drug, Opdivo (nivolumab), for use in a clinical study sponsored by Bavarian Nordic. The clinical study will combine BMS' Opdivo with Bavarian Nordic's cancer immunotherapy candidate, CV301, in treating patients with previously treated non-small cell lung cancer (NSCLC).

Bavarian Nordic will retain all commercial rights for CV301. There is no obligation on behalf of BMS, beyond contributing drug material. CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-expressed in major cancer types, including lung, bladder and colorectal cancer.

Opdivo is projected to be a blockbuster drug by some analysts. In 2015, it had global sales of $942 million, and a recent Thomson Reuters analysis projects that 2019 sales will reach nearly $8.9 billion.

In the US, Opdivo is approved for patients with NSCLC with progression on or after platinum-based chemotherapy. Opdivo is also approved as a single agent for treating BRAF V600 wild-type unresectable or metastatic melanoma and as a single agent for treating BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also approved in combination with Yervoy (ipilimumab) for treating unresectable or metastatic melanoma and for treating advanced renal cell carcinoma that has received prior anti-angiogenic therapy. The drug is also indicated for patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.

In related news, BMS hit a stumbling block recently when Opdivo did not meet its primary endpoint in a trial investigating use of the drug as a monotherapy in patients with previously untreated advanced NSCLC whose tumors expressed PD-L1 at ≥ 5%.

Source: Bavarian Nordic

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